Biosafety Level

Certified Reference Materials (CRMs)

Storage:
NIST-8398 is stored at −20°C for long-term storage, or in the dark at 4°C for short-term storage (if use is imminent). Please limit freeze-thaw cycles

Applications:
This Reference Material (RM) is intended for assessing performance of human genome sequencing, including whole genome sequencing, whole exome sequencing, and more targeted sequencing such as gene panels. Specifically, the material can be used to obtain estimates of true positives, false positives, true negatives, and false negatives for variant calls. This genomic DNA is to be analyzed as any other processed, extracted DNA. It can be used to assess sequencing library preparation, sequencing machines, and the bioinformatics steps of mapping, alignment, and variant calling. This RM is not intended to assess subsequent bioinformatics steps such as functional or clinical interpretation.

This RM is intended to provide a whole human genome sample and accompanying reference values to assess performance of variant calling from genome sequencing

This Reference Material (RM) is intended to provide a whole human genome sample and accompanying reference values to assess performance of variant calling from genome sequencing. This RM contains human genomic deoxyribonucleic acid (DNA) extracted from a large growth of the human lymphoblastoid cell line GM12878. A unit of RM 8398 consists of a single vial containing approximately 10 μg of genomic DNA, with the peak of the nominal length distribution longer than 48.5 kb, as referenced by Lambda DNA, and the DNA is in TE buffer (10 mM TRIS, pH 8.0, 1 mM EDTA, pH 8.0).

See the NIST Certificate of Analysis for directions for use and quality control specifications.

SRM NIST-2372 is intended primarily for use in the value assignment of human genomic DN forensic quantitation materials. It is not intended for any human or animal clinical diagnostic use. SRM 2372 consists of three well-characterized human genomic DNA materials solubilized in 10 mmol/L 2-amino-2-(hydroxymethyl)-1,3-propanediol hydrochloride (Tris HCl) and 0.1 mmol/L ethylenediaminetetraacetic acid disodium salt (disodium EDTA) using deionized water adjusted to pH 8.0 buffer (TE-4). The three component genomic DNA materials, labeled A, B, and C, are derived from a single male donor, multiple female donors, and multiple male and female donors, respectively. A unit of the SRM consists of one sterile 2 mL vial of each component, each vial containing approximately 110 μL of DNA solution. Each of these vials is labeled and is sealed with a color–coded screw cap.

See the NIST Certificate of Analysis for directions for use and quality control specifications.

Applications:
For use in testing and calibration in ISO 17025 accredited laboratories, to challenge assay performance, validate or compare test methods, and to establish sensitivity, linearity and specificity during assay validation or implementation. ISO Guide 34:2009.

Store at - 80°C or colder in a manual defrost freezer. Avoid freeze-thawing. Alternatively, product can be stored at -20°C or colder, but stability at this temperature has not been tested by the ATCC and is not guaranteed.

Applications:
For use in testing and calibration in ISO 17025 accredited laboratories, to challenge assay performance, validate or compare test methods, and to establish sensitivity, linearity and specificity during assay validation or implementation. ISO Guide 34:2009.

Store at - 80°C or colder in a manual defrost freezer. Avoid freeze-thawing. Alternatively, product can be stored at -20°C or colder, but stability at this temperature has not been tested by the ATCC and is not guaranteed.

For use in testing and calibration in ISO 17025 accredited laboratories, to challenge assay performance, validate or compare test methods, and to establish sensitivity, linearity and specificity during assay validation or implementation. ISO Guide 34:2009.

Store at - 80°C or colder in a manual defrost freezer. Avoid freeze-thawing. Alternatively, product can be stored at -20°C or colder, but stability at this temperature has not been tested by the ATCC and is not guaranteed.

Applications:
For use in the standardization of forensic and paternity quality assurance procedures for polymerase chain reaction (PCR)-based genetic testing, for instructional law enforcement or non-clinical research purposes, and for quality assurance when assigning values to in-house control materials. It is not intended for any human or animal clinical diagnostic use.

SRM NIST-2391c is composed of well-characterized human deoxyribonucleic acid (DNA) in two forms: genomic DNA (Components A through D) and DNA to be extracted from cells that have been spotted onto 903 paper (Component E) and FTA paper (Component F).

Component

Description

Amount

Concentration(a)

A

Anonymous single-source female genomic DNA in TE-4 buffer

50 μL

1.1 – 2.1 ng/μL

B

Anonymous single-source male genomic DNA in TE-4 buffer

50 μL

1.1 – 2.1 ng/μL

C

Anonymous single-source male genomic DNA in TE-4 buffer

50 μL

1.1 – 2.1 ng/μL

D

Mixed-source (Components A and C) genomic DNA in TE-4 buffer

50 μL

1.1 – 2.1 ng/μL

E

Anonymous single-source female cells spotted on 903 paper

Two 6 mm punches

7.5 × 104 cells per punch

F

Anonymous single-source male cells spotted on FTA paper

Two 6 mm punches

7.5 × 104 cells per punch

See the NIST Certificate of Analysis for directions for use and quality control specifications.

For use in testing and calibration in ISO 17025 accredited laboratories, to challenge assay performance, validate or compare test methods, and to establish sensitivity, linearity and specificity during assay validation or implementation. ISO Guide 34:2009.

For use in testing and calibration in ISO 17025 accredited laboratories, to challenge assay performance, validate or compare test methods, and to establish sensitivity, linearity and specificity during assay validation or implementation. ISO Guide 34:2009.

Store at - 80°C or colder in a manual defrost freezer. Avoid freeze-thawing. Alternatively, product can be stored at -20°C or colder, but stability at this temperature has not been tested by the ATCC and is not guaranteed.

For use in testing and calibration in ISO 17025 accredited laboratories, to challenge assay performance, validate or compare test methods, and to establish sensitivity, linearity and specificity during assay validation or implementation. ISO Guide 34:2009.

Store at - 80°C or colder in a manual defrost freezer. Avoid freeze-thawing. Alternatively, product can be stored at -20°C or colder, but stability at this temperature has not been tested by the ATCC and is not guaranteed.

Applications:
Used to assign ratios of the human epidermal growth factor 2 gene (HER2; the official gene symbol ERBB2) to unamplified reference genes. Measurements of the amplification (increased copies) of the HER2 gene in breast cancer samples are used as a biomarker for determining the classification for breast cancers

SRM NIST-2373 consists of genomic DNA extracted from five breast cancer cell lines with different amounts of amplification of the HER2 gene. The five purified genomic DNAs were solubilized in a buffer consisting of 10 mmol/L tris(hydroxymethyl)aminomethane and 0.1 mmol/L ethylenediaminetetraacetic acid disodium salt (EDTA) pH 8.0 (TE–4). The five components are genomic DNA materials derived from human cell lines SK-BR-3, MDA-MB-231, MDA-MB-361, MDA-MB-453, and BT-474, labeled A, B, C, D, and E, respectively. A unit of SRM 2373 consists of five vials, one of each component, containing approximately 100 μL of DNA solution. Each of these vials is labeled and is sealed with a color-coded screw cap.

See the NIST Certificate of Analysis for directions for use and quality control specifications.